DOH chief suspects Sanofi hiding info on dengue vaccine trials

Gillan Ropero, ABS-CBN News

Posted at Dec 09 2017 10:31 PM

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The Philippines is seeking more information about the Dengvaxia clinical trials after a meeting with pharmaceutical giant and vaccine maker Sanofi Pasteur turned out to be unproductive. 

Health Secretary Francisco Duque said health officials met with Sanofi Pasteur executives on Friday to get more information about the controversial vaccine.

"Ang sabi ko sa kanila bigyan mo kami ng data. Kung ano ang binigay niyo sa World Health Organization, bigyan niyo rin kami at may mga tinanong kami sa kanila, hindi nila masagot. Kailangan daw nilang pag-aralan pa yung kanilang data," Duque said in a radio DZMM interview. 

"Sa madaling salita, wala kami masyadong na-achieve dun kasi nga mas gusto na namin na antayin na lang ang WHO."

The health chief said they decided to await further recommendation from the World Health Organization, which will convene on December 12, due to the vaccine maker's "very technical presentation."

"Napagusapan namin antayin na lamang yung WHO. Baka mas maintindihan namin kasi very technical eh, hindi naman kami experts diyan sa kanilang clinical trial study. Mahirap naman yung nagmamagaling ka pa sa mas magaling," he said.

Duque earlier said the Department of Health will seek a refund from Sanofi and bring it to court if it is found to have withheld information regarding the vaccine.

He told DZMM he has a hunch that the pharmaceutical giant did not disclose information about the vaccine in the rush to have it commercially available. 

"Ang kutob ko mukhang may alam itong Sanofi na hindi sinasabi nung anti-mano na kinomercialize nila yung bakuna eh. Tingin ko baka may mga information na hindi nadisclose eh," Duque said.

Earlier, the health chief noted that Sanofi seemed to downplay the definition of "severe dengue" when it said that people who got Dengvaxia shots but had not been previously infected by dengue are at risk of getting "more cases of severe disease."

"Ang sinasabi nila wala silang nakitang Grade 4 [symptoms of dengue] pero hindi nila sinabi sa press release na nakakita sila ng Grade 3 [symptoms]. That's what I want to ask them. Why did you say you observed Grades 1 and 2 [symptoms] and you never observed Grade 4. But you didn't say you observed Grade 3. Why? They should have been more transparent and forthright," he said in an ANC Headstart interview. 

A Department of Foreign Affairs (DFA) report earlier revealed then Health Secretary Janette Garin met with Sanofi-Pasteur officials in Paris last June 2015 to discuss, among others, the price of the vaccine, how to create a demand for it in the Philippines, and a strategy to justify its inclusion in the succeeding Philippine budget.

The Philippines was the 1st country in Asia to approve the vaccine for individuals aged 9 to 45 years old in December 2015.

The government spent P3.5 billion to purchase Dengvaxia for one million public school children in regions reported to have the highest incidence of dengue in 2015.

As of November, the vaccine has been given to about 830,000 children in Metro Manila, Southern Luzon, Central Luzon and Central Visayas, per government data. 

It was only last week that Sanofi issued a warning against its own dengue vaccine, saying the drug may cause more severe symptoms on people who have not contracted the mosquito-borne disease. 

Duque meanwhile said he would have been "more conservative and prudent" in response to former Health Secretary Janette Garin's decision to purchase the vaccine.

"Well, siyempre yung gusto niyang panigan, pinanigan niya pero ang sa akin kasi, I would have been more conservative and prudent kasi buhay ng tao," he said.

"Ako kasi laging merong prinsipyong pinaniniwalaan, ito yung it is better to err on the side of caution. Magkamali man ako, okay lang basta nasa panig ako ng kaligtasan," he added.

Duque said the vaccine should have been administered to a smaller number of children like in Brazil, where he said only 300,000 were vaccinated.

"So yung isang milyong binakunahan tingin ko masyadong marami, masyadong mabilis na dapat siguro nagantay pa ng mas kaunti pang panahon para talagang nakasisiguro ka sa safety and efficacy or benefits ng isang bakuna," he said.